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RecruitingNCT07732972Updated Jul 29, 2026

Multilevel Multimodal Neurophysiological Integration for Investigating the Network Modulatory Mechanisms of Epidural Spinal Cord Stimulation

An observational study in Spinal Cord Injury(SCI), sponsored by Buddhist Tzu Chi General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Buddhist Tzu Chi General Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
20 Years to 70 Years
Sex
All
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Study summary

This study will examine how the brain, spinal cord, and muscles communicate in people with spinal cord injury. Researchers will use noninvasive brain and muscle recordings together with spinal electrical recordings to better understand how epidural spinal cord stimulation (EES) affects nerve function. The results may help develop more effective and personalized rehabilitation treatments for people with spinal cord injury.

Read the detailed description

This study aims to investigate the neural activity of individuals with SCI by simultaneously recording spinal electrograms (SEG), electroencephalography (EEG), and electromyography (EMG). Multimodal neurophysiological recordings will be used to evaluate communication between the brain, spinal cord, and muscles before and after EES. Clinical assessments of neurological function, upper extremity motor performance, and functional independence will also be performed to examine the relationship between electrophysiological changes and functional recovery.

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Conditions studied

  • Spinal Cord Injury(SCI)
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In context

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 332 observational studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Buddhist Tzu Chi General Hospital is the lead sponsor of 88 studies on the registry; 20 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Neurosurgery patient at Buddhist Tzu Chi General Hospital, Hualien

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

A. Non-Spinal Cord Injury (Non-SCI) Group

  • Individuals without spinal cord injury.
  • Patients diagnosed with chronic neuropathic pain who meet the criteria for routine temporary epidural spinal cord stimulation (EES) implantation therapy.
  • Patients who have undergone temporary epidural spinal cord stimulation (EES) implantation.
  • Ability to understand and follow motor instructions.
  • Age between 20 and 70 years. B. Spinal Cord Injury (SCI) Group
  • Patients with chronic spinal cord injury.
  • Patients who have undergone temporary epidural spinal cord stimulation (EES) implantation.
  • American Spinal Injury Association Impairment Scale (AIS) grades A-D.
  • Spinal cord injury levels between C3 and L1.
  • Ability to understand and follow motor instructions.
  • Age between 20 and 70 years.

Exclusion criteria

Exclusion Criteria:

  • Individuals with severe psychiatric disorders or cognitive impairments, including major depressive disorder, schizophrenia, or dementia, that may affect their ability to understand the study procedures or comply with study instructions.
  • Individuals who are unable to maintain consciousness, follow instructions, or complete study tasks, including motor tasks, isometric contractions, or resting-state tasks.
  • Individuals with severe medical conditions and unstable clinical status, such as uncontrolled cardiovascular disease, severe infection, respiratory failure, or other conditions deemed unsuitable for study participation by the attending physician.
  • Individuals with abnormal positioning, inadequate fixation, or complications related to temporary epidural spinal cord stimulation (EES) leads, including infection, significant pain, or neurological deterioration, as determined by clinical evaluation to be unsuitable for study recordings.
  • Individuals currently using medications that may significantly affect neurophysiological signals, such as high-dose sedatives, anesthetic agents, or other medications considered by the research team to interfere with data interpretation.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group without spinal cord injury

    Adults aged 20-70 years without spinal cord injury who have chronic neuropathic pain and have undergone temporary epidural spinal cord stimulation (EES). Neural activity will be evaluated using simultaneous spinal electrogram (SEG), electroencephalography (EEG), and electromyography (EMG) recordings during EES.

  • Spinal cord injury group

    This cohort includes adults aged 20-70 years with chronic spinal cord injury who have undergone temporary epidural spinal cord stimulation (EES). Participants with AIS grades A-D and injury levels from C3 to L1 will be included. Neural activity will be evaluated using spinal electrogram (SEG), electroencephalography (EEG), and electromyography (EMG) recordings during EES.

    Device: participants will be divided into two disease cohorts: the spinal cord injury (SCI) group and the non-spinal cord injury (non-SCI) group.

Interventions

  • Deviceparticipants will be divided into two disease cohorts: the spinal cord injury (SCI) group and the non-spinal cord injury (non-SCI) group.

    This observational case-control study includes two groups: a spinal cord injury (SCI) group and a non-SCI group. The SCI group consists of patients diagnosed with SCI by physicians. Both groups have undergone temporary epidural spinal cord stimulation (EES), and spinal electrophysiological signals will be recorded during stimulation in the SCI group to evaluate neural activity.

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What researchers measure

Primary outcomes

  1. Peak-to-peak amplitude of spinal evoked responses

    Peak-to-peak amplitude of spinal evoked responses will be measured in microvolts (µV) to quantify the magnitude of neural activation under different stimulation conditions.

    Time frame: baseline; at 7、20 days after the implantation

  2. Latency of spinal evoked responses

    Response latency of spinal evoked responses will be measured in milliseconds (ms) from stimulus onset to the onset or peak of the response to evaluate neural conduction characteristics.

    Time frame: baseline; at 7、20 days after the implantation

  3. Area under the curve (AUC) of spinal evoked responses

    The area under the evoked response waveform will be calculated in µV、RMT(%)) to quantify the overall neural response elicited by stimulation.

    Time frame: Baseline; at 7、20 days after the implantation

  4. Recruitment curve of spinal evoked responses

    Recruitment curves will be constructed by plotting peak-to-peak amplitude (µV) to characterize spinal neural excitability and recruitment properties.

    Time frame: baseline; at 7、20 days after the implantation

  5. EEG spectral power

    EEG spectral power will be calculated using Morlet wavelet transform and expressed in decibels (dB) for the theta (θ), alpha (α), beta (β), and gamma (γ) frequency bands to quantify changes in neural oscillatory activity.

    Time frame: baseline; 7、20 days after the implantation

  6. SEG spectral power

    SEG spectral power will be calculated using Morlet wavelet transform and expressed in decibels (dB) for the theta (θ), alpha (α), beta (β), and gamma (γ) frequency bands to quantify changes in spinal neural oscillatory activity.

    Time frame: baseline; 7、20 days after the implantation

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07732972
Lead sponsor
Buddhist Tzu Chi General Hospital
Responsible party
Sponsor
First posted
Jul 29, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Jul 29, 2026

Study contacts

Yu-Chen Chen, M.D., Ph.D
Contact
spring810569@gmail.com
+886-3-856-1825 ext. 13054
Sheng-Tzung Tsai, M.D., Ph.D.
Contact
flydream.tsai@gmail.com
+886-3-856-1825 ext. 13054
Yu-Chen Chen, M.D., Ph.D
principal investigator · Hualien Tzu Chi General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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